Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 75 Years|
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Horizon Therapeutics Ireland DAC|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Farah Ali, MD|
|Principal Investigator Affiliation||Horizon Therapeutics|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Argentina, France, Greece, Israel, Korea, Republic of, Mexico, Netherlands, Poland, Portugal, Spain, United States|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Diffuse Cutaneous Systemic Sclerosis, Sclerosis, Systemic|
Experimental: HZN-825 300 mg once daily (QD)
300mg oral tablets given in the morning and placebo in the evening
Experimental: HZN-825 300 mg twice daily (BID)
300mg oral tablets given in the morning and evening
Placebo Comparator: Placebo
Placebo will be given orally in the morning and evening
Drug: - HZN-825 BID
300 mg oral tablets BID
Drug: - Placebo
Drug: - HZN-825 QD
300 mg oral tablets QD
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.